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FDA 510(k)

ORTHOVIS PREOPERATIVE PLAN

K-Number: K133367 · 2013-12-20

ApplicantCustom Orthopaedic Solutions
Decision Date2013-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOVIS PREOPERATIVE PLAN is the device name listed in this FDA 510(k) record. The listed applicant is Custom Orthopaedic Solutions. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K133367. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOVIS PREOPERATIVE PLAN?

ORTHOVIS PREOPERATIVE PLAN is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Custom Orthopaedic Solutions. The 510(k) number is K133367.

When did ORTHOVIS PREOPERATIVE PLAN receive FDA 510(k) clearance?

ORTHOVIS PREOPERATIVE PLAN received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133367.

Who is the listed applicant for ORTHOVIS PREOPERATIVE PLAN?

The FDA 510(k) record lists Custom Orthopaedic Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOVIS PREOPERATIVE PLAN?

The FDA product code for ORTHOVIS PREOPERATIVE PLAN is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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